By Deborah Borfitz

March 16, 2021 | A lot of technology companies talk about the importance of patient input on the products they build, but Medidata is the first to hire patient advocates to provide feedback throughout the development life cycle—specifically, the patient cloud products it deploys in clinical trials, says Alicia Staley, senior director of patient engagement. “We’ve put a process in place to hold our own feet to the fire,” she says. “If our patient advocates haven’t looked at something rolling out the door, an explanation is expected as to why not.”

That level of commitment to amplifying the patient voice helped earn Medidata the grand prize in the 2021 Participant Engagement Award during the recent Summit for Clinical Ops Executives (SCOPE). Its project—aptly named Patient Centricity by Design—describes a rigorous process whereby paid patient advocates regularly huddle up with engineering and design staff to preemptively address the needs of end users. [Editor’s Note: See below for the entries by runners up Datacubed Health and Havas Lynx Faze.]

Every step of product development has this now-virtual “patient design studio” component to ensure the patient perspective is considered and understood, says Staley, a three-time cancer survivor who had no trouble assembling a crackerjack team of advocates. In addition to her 20 years of experience in software design and information systems management, she has worked in the advocacy field for the past decade and serves as the ePatient advisor for Stanford Medicine X, a technology conference whose design thinking mentality has been adopted by Medidata’s patient advocacy team.

Seven of Medidata’s 12 current advocates are graduates of the Medicine X program, she notes, but they are otherwise diverse in multiple respects. For starters, they represent different ages and therapeutic areas and are at different points in their treatment journey.

Of the 75% who have participated in a clinical study, all trial phases are represented, Staley adds. Although most of the advocates hail from the U.S., two of the 12 are well known in the European Union and one is from Japan, and they have different backgrounds and technical proficiencies.

All were “interested, willing, and able” to put in the upfront work of learning about Medidata’s patient-facing software solutions and support of the clinical trials industry, says Staley. The team typically meets via Zoom for 10 to 20 hours per month. In addition to assisting with products under development, patient design studios are also convened to discuss concepts for clinical trial tools being considered for future development and to look “with a new lens” at mature solutions for opportunities to add patient-pleasing enhancements with the next product release.

The team is expected to grow to 15 by July, when the initiative hits its third birthday, which will likely be the maximum so long as meetings are being held virtually, Staley says. As the program scales, the intention is to build out advocates as subject matter specialists in areas such as wearable devices and sensors, health and tech literacy, and how clinical trial opportunities are presented to patients through consent forms.

Pandemic Pivot

Medidata’s patient cloud products include a patient portal and digital tools for consent, patient-reported outcomes, and clinical outcomes assessment, plus wearable sensors deployed for clinical trials the company is supporting, says Staley.

When the program started, patient design studios were a multi-day event that happened in a training room in New York or San Francisco, she says. The pandemic transitioned the team to virtual meetings on Zoom using virtual tools to replicate the shared whiteboard, sticky notes, and notepads of an in-person collaborative. Long term, a hybrid of the two approaches will likely prevail, she adds.

The COVID-19 outbreak, while disruptive, taught the Medidata team a lot about what it means to be a patient, Staley says. “A number of our patient advocates are still on active clinical trials, and a couple of them are metastatic cancer patients using clinical trials as an extension of their life. Seeing what they are going through to achieve continuity in their [care] in the face of a pandemic was eye opening for all of us.”

The advocacy team served on multiple patient design studios last year for a COVID-19 symptom tracker Medidata was looking to roll out, she notes. Their feedback was solicited early on and ensured that additional information was available about why certain questions were being asked. They were particularly vocal regarding the “look and feel” of the application, including how information was presented on the screen.

Measuring Success

A long-term goal and “ultimate marker of success,” says Staley, is to prove the impact of the patient advocates on the experiences and satisfaction of clinical trial participants using Medidata software products. This year, as a first step, she will be engaged in conversations about appropriate measures of those endpoints.

The plan is to construct a way to trace the input of patient advocates through the development life cycle, Staley says, and then begin measuring an application’s usage before versus after they had an opportunity to weigh in with suggested enhancements. Measures will initially focus on usability and the user experience to help build the case for metrics around patient engagement, which presumably would look better when applications were “certified” by the advocacy team.

Unsurprisingly, clients are pleased with the steps Medidata has been taking to improve the patient experience and prove out the validity of its work using data. “We have had the opportunity to invite some sponsors in to participate in our design studios and we got phenomenal feedback and wonderful comments from [them] on how they want to see the program evolve and to be involved going forward,” says Staley. Cross-collaborative work between patient advocates and sponsors is expected to start this year.

Separately, Medidata has been facilitating discussions about clinical trials on Twitter with the hashtag #CTSM (clinical trials social media), playing off the hashtag #BCSM (breast cancer social media) Staley has used over the past decade for regular Monday night chats with over 250 other breast cancer survivors around the world. After being diagnosed with Hodgkin’s lymphoma as a sophomore in college, Staley was subsequently diagnosed with breast cancer in 2004 and again in 2008. She turned to Twitter after hospital support groups started shutting down for lack of funding.

2021 Participant Engagement Awards Runners-Up

Geofencing For Data Quality: Datacubed Health snagged the second-place spot in the juried Participant Engagement Award competition for its project preventing low-quality data and patient dropouts in vaccine trials being conducted by a top-five pharma company. As detailed in the entry form, it automated case alerts to capture higher quality data and applied principles of behavioral science to strengthen patient engagement, resulting in a 95% capture rate for adverse events and 95% patient compliance.

The enabling technology is geofencing, which draws a virtual fence around care sites and sends out alerts via a Datacubed Health app on patients’ phone when the fence is breached, signaling some adverse event. The alerts, in turn, generate different steps associated with adverse event capture.

Data capture rates in vaccine trials are notoriously low, typically requiring trials to enroll 30% to 40% more patients to compensate for the loss in statistical power. Sponsors are effectively surrendering about 30% of their trial budget due to low data quality, and geofencing offers a frictionless way to capture the requisite data without placing calls or doing manual data entry.

In the referenced case, the client was running a trial with a low-frequency adverse event associated with hospital visits that members of the research team were trying to capture by phoning participants every three months. This was contributing to a 60% data capture rate, which Datacubed Health’s geofencing solution improved by roughly 35 percentage points, as reported by Paul Glimcher, Ph.D., the company’s chairman and chief scientific officer.

Getting Real About IBD: The third-place winner recognized during award ceremonies for its “Suffering Behind the Selfies” clinical trial recruitment campaign for Arena Pharmaceuticals was Havas Lynx Faze. The campaign uses insights from patients with inflammatory bowel disease (IBD) and seeks to connect with an audience “fatigued with symptom-based advertising” by validating their feelings, discomfort, and sense of isolation—and addressing the benefits of study participation based on the complicated realities of living with IBD.

As described in the entry form, patients from around the world were extensively interviewed and involved in all campaign touchpoints. Their selfie photography was incorporated into print advertising and online display media, and quotes from their Instagram Stories and Facebook posts were turned into authentic messaging. Their longer-form writing was shared via dedicated story-pages in the patient section of the recruitment website.

Launched at the height of the global pandemic, the campaign nonetheless resulted in hundreds of IBD patients opting to sign up for the phase 3 ulcerative colitis trial at a 75% cost saving relative to the industry benchmark, reported Mark Wilkins, Faze’s senior patient experience director. Less than two months after launching, the campaign was delivering randomized patients.

Patient recruitment for the first arm of the study was successfully completed in December 2019, he states, and the campaign will now support the study’s second arm as well as a phase 2 and phase 3 study recruiting patients for Crohn’s disease.